The present invention relates to methods and devices which retain and position a breast in a graduated reference frame while the patient in either in the supine or prone position for the purposes of instrumenting the breast for various procedures and techniques including but not limited to surgery, biopsy, tissue retraction, deployment of devices, radiography, imaging, spatial positioning, and repeatability.
1. Objects of the Invention
It is an object of the invention to provide a method and device that will support the breast in a position that enhances surgical and biopsy procedures using a variety of devices, methods, and techniques.
It is another object of the invention to provide efficient stabilization and traction of the breast as well as provide a means for retraction of tissue during surgical procedures of the breast.
It is still another object of the invention to provide support, guidance, and deployment of surgical instruments and devices during surgical and biopsy procedures of the breast.
It is still yet another object of the invention to provide a method and device to repeatedly position the breast in a reference frame for the purposes of survey the breast for a biopsy or surgical procedure or repeatedly position the breast for diagnostic radiography or therapeutic radiation.
It is an object of the invention to provide a reference frame encompassing the breast and when used in combination with imaging and processing techniques such as CT or MRI, the surgeon can precisely locate a lesion relative to the reference frame.
It is another object of the invention to provide support for the breast during radiographic techniques such as mammography while the patient is lying on their back or in the supine position.
In yet another objective, the invention provide an operative platform for a variety of excisional and surgical devices to be used in a more accurate and repeatable manner.
2. Summary of the Invention
Recently, several patents surrounding the use of devices for minimally invasive breast biopsy or the excision of breast tissue have been issued. For example, Lee and Vetter in U.S. Pat. No. 6,022,362 disclose an excisional biopsy device consisting of a tubular member with a bowed cutting edge at the distal aspect of the device. After placing the device adjacent to a suspected lesion in the breast, the bowed cutting tool is deployed and the device is manually rotated which excises tissues for removal. In particular, the instrument is supported and deployed manually. The present disclosure describes methods and devices that would allow the Lee and Vitter device to be integrated into the present invention resulting in improved operation of their patent.
In another example, Russin in U.S. Pat. Nos. 5,795,308; 5,807,276; and 6,080,114 describe a biopsy device and method wherein a rigid K-wire is positioned through a breast lesion to be removed under radiographic guidance. An introducer tube is advanced over the rigid K-wire and placed into position and the K-wire is removed. Next, a rigid rod with flexible steel hooks is advanced through the tube, exits the distal aspect of the tube and engages the breast tissue. The tube is withdrawn and series of instruments are passed over the anchored rigid rod resulting in the removal breast tissue using a cannula. To retain and position the breast, a stabilizing tong is disclosed such that the breast is compressed along the axis of the rod to foreshorten the distance from skin to breast lesion. Compression of the breast along the axis of the rod results in radial expansion of the breast tissue including the lesion the lesion to be removed (Poisson effect). This may result in an excisional biopsy that either leaves some of the lesion remaining in the breast as a result of a larger lesion in a plane perpendicular to the long axis of the rod, or compel the operator to use a larger cannula to capture all of the radially expanded lesion. The present invention disclosed herein, describes a device that would allow Russin to practice his invention in a more efficient and precise manner.
Wire needle localization is a surgical technique frequently invoked by surgeons to biopsy lesions in the breast. A wire is inserted adjacent to a breast lesion under the guidance of radiography. The wire serves as a marker which is palpated by the surgeon at the time of and during surgery in order to estimate the dissection route to remove the breast tissue to be biopsied as well as guide to estimate the thickness of the margin during the procedure. The surgical objective of the biopsy is to remove an adequate tissue sample such that the wire and the lesion are at the center of the sample surrounded by an adequate margin thickness of normal breast tissue. About 20% of wire needle localizations submitted for pathologic evaluation are returned as malignant. Of these, many have dirty margins meaning that some of the malignant was left in the breast compelling the surgeon to return to the operative site in the breast and remove additional tissue that is suspect of the malignant tumor.
Surgery and biopsy of the breast using the aforementioned methods and devices is typically performed with the patient lying on their back. In this position, the breast will lay somewhat off center and lateral to the patient""s chest, the amount of which is dependent primarily on the size of the breast as well as the age of the patient. Managing the breast during surgical procedures can be time consuming and inefficient. Stabilization of the breast using the present invention will result in more efficient and accurate of devices and methods for biopsy and surgical procedures.